- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04108676
Effect of Omeprazole on PK of Fluzoparib in Healthy Male Subjects
July 28, 2022 updated by: Jiangsu HengRui Medicine Co., Ltd.
a Single-center, One-arm, Open, and Fixed Sequences Study to Evaluate the Effects of Omeprazole on the Pharmacokinetics of Fluzoparib in Healthy Male Volunteers
The purpose of this study is to evaluate the Effect of Omeprazole on the Pharmacokinetics of Fluzoparib in Healthy male Adults.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hunan
-
Changsha, Hunan, China, 410013
- The third xiangya hospital Hospital,of central south university
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Age 18 to 50 years (including both ends), male;
- Male volunteers have a body weight ≥ 50.0 kg and a body mass index (BMI) between 19 and 28 kg/m2 (including both ends);
- Male volunteers are willing to have no birth plans in the next 6 months and voluntarily take effective contraceptive measures;
- Volunteers voluntarily sign written informed consent.
Exclusion Criteria:
- Previous or currently suffering from circulatory system (myocarditis, coronary heart disease, pathological arrhythmia, stroke, etc.), endocrine system, nervous system, digestive system (peptic ulcer, colitis, pancreatitis, etc.), respiratory system (Invasive lung disease, pneumonia, dyspnea, etc., urogenital system (chronic kidney disease, renal insufficiency, renal anemia), hematology, immunology, psychiatry and metabolic abnormalities, etc. Result of any other disease;
- A history of allergies to drugs, foods or other substances; allergies, including a history of severe drug allergies or drug allergies; a history of allergies to Fluzoparib capsules or omeprazole magnesium enteric-coated tablets
- Those who have undergone surgery within 4 weeks prior to the trial or who plan to undergo surgery during the study;
- Those who have taken any drugs or health care products (including Chinese herbal medicines) within 14 days before the test;
- Any drug that inhibits or induces liver metabolism of the drug within 30 days prior to the test (eg, inducer - barbiturate, carbamazepine, phenytoin, glucocorticoid, omeprazole; inhibitor - SSRI resistance) Depressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines;
- Those who participated in any clinical trial and took any clinical trial drug within 3 months prior to the trial;
- Donate blood or massive blood loss (≥200 mL), receive blood transfusion or use blood products within 3 months before enrollment;
- One or more non-pharmaceutical contraceptives cannot be used during the volunteer trial;
- Those who have special requirements for diet and cannot follow the unified diet;
- Drink excessive amounts of tea, coffee and/or caffeinated beverages (8 cups or more, 1 cup = 250 mL) per day;
- smokers or smokers with more than 5 cigarettes per day for the first 3 months of the trial or who cannot stop using any tobacco products during the trial period;
- Alcoholics or those who regularly drink alcohol within 6 months prior to the test, ie drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) or during the test period Stop using any alcoholic products;
- Drug abusers or soft drugs (eg marijuana) 3 months prior to the trial or hard drugs (eg cocaine, phencyclidine, etc.) 1 year prior to the trial; and nicotinic positive volunteers
- Abnormal vital signs (systolic blood pressure <90 mmHg or >140 mmHg, diastolic blood pressure <50 mmHg or >90 mmHg; pulse <50 bpm or >100 bpm) or physical examination, electrocardiogram, laboratory examination, imaging examination abnormalities Clinically significant (subject to the judgment of the clinical research doctor);
- have a history of dysphagia or any history of gastrointestinal disease that affects drug absorption;
- Those who have undergone any surgery within the first 6 months of screening; have previously undergone any surgery that affects gastrointestinal absorption (including gastrectomy, bowel resection, stomach reduction surgery, etc.);
- The volunteer refused to discontinue any beverage containing methylxanthine, such as caffeine (coffee, tea, cola, chocolate, etc.) or alcoholic beverages or any juice, 48 hours before the study drug was administered until the end of the study;
- Creatinine clearance (CLCr) <80 mL/min, or creatinine above the upper limit of normal;
- Volunteers may not be able to complete the study for other reasons or those the investigator believes should not be included.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: single arm
Drug: Fluzoparib Drug: Omeprazole
|
PARP inhibitor
proton pump inhibitor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Plasma Concentration (Cmax) of Fluzoparib:
Time Frame: through study completion, up to 24 weeks
|
Cmax
|
through study completion, up to 24 weeks
|
Area Under the Plasma Concentration-Time Curve From 0 to t of Fluzoparib:
Time Frame: through study completion, up to 24 weeks
|
AUC0-t
|
through study completion, up to 24 weeks
|
Area Under the Plasma Concentration-Time Curve From 0 to infinity of Fluzoparib:
Time Frame: through study completion, up to 24 weeks
|
AUC0-∞ (if available)
|
through study completion, up to 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety in terms of Adverse Events Assessments
Time Frame: through study completion, up to 24 weeks
|
Adverse Events Assessments (NCI-CTC AE 5.0)
|
through study completion, up to 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Guoping Yang, PhD, The Third Xiangya Hospital of Central South University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 7, 2019
Primary Completion (ACTUAL)
September 18, 2019
Study Completion (ACTUAL)
November 18, 2019
Study Registration Dates
First Submitted
September 19, 2019
First Submitted That Met QC Criteria
September 27, 2019
First Posted (ACTUAL)
September 30, 2019
Study Record Updates
Last Update Posted (ACTUAL)
July 29, 2022
Last Update Submitted That Met QC Criteria
July 28, 2022
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FZPL-I-111
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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